Every day I experience life in the world of healthcare IT, supporting 3000 doctors, 18000 faculty, and 3 million patients. In this blog I record my experiences with infrastructure, applications, policies, management, and governance as well as muse on such topics such as reducing our carbon footprint, standardizing data in healthcare, and living life to its fullest.

Wednesday, December 31, 2014

2014 was quite a year. Thinking back to December 2013, I cannot believe that so much has happened. Let’s take a look at the major HIT events that shaped 2014 and what they portend for 2015

Affordable Care Act - despite challenges with healthcare.gov and state health insurance exchanges, the notion of moving forward with an open insurance marketplace and accountable care got traction. The IT needed to meet the needs of the patient centered medical home, the ACO, and Care Management spawned a new type of software - the care management medical record. Not many products exist and none are mature, but HIMSS was filled with promises of workflow engines, population health, and protocol driven care management tools. 2014 made it clear that the EHR is just a starting point and over time there will be a new generation of tools used by clinicians and non-clinician extenders to keep people healthy, not just record their encounters when they’re sick. Hopefully we’ll see maturing products in 2015.

Meaningful Use/Standards - 2014 was really the first year we could take a look back at the Meaningful Use program. I think we can conclude that Meaningful Use Stage 1 was generally perceived as a positive step, laying the foundation for EHR adoption by hospitals and professionals. Stage 2 was aspirational and a few of the provisions - Direct-based summary exchange and patient view/download/transmit required an ecosystem that does not yet exist. The goals were good but the standards were not yet mature based on the framework created by the Standards Committee. At this point the only way out of the readiness/adoption challenge is to allow more time for the ecosystems to develop by changing the attestation period in 2015 to 90 days. Although Direct/CCDA was a reasonable starting point for 2014, the future belongs to FHIR/REST/OAuth, which are going to be much easier to implement. We need to be careful not to incorporate FHIR into any regulatory program until it has achieved an objective level of maturity/adoption

HIPAA Omnibus Rule - 2014 saw increased federal and state enforcement of the HIPAA Omnibus Rule with record fines for security breaches at a time when the nature of security attacks became increasingly sophisticated - witness the Home Depot, JP Morgan, and Target breaches as well as denial of service attacks on numerous healthcare and non-healthcare organizations. Healthcare as an industry directed substantial resources toward improving the security protections of their networks in 2014. It will be interesting to look back at this era in several years and ask the question if million dollar fines for stolen laptops/smartphones was a helpful policy or if other enablers such as the evolution of security technologies and culture change were more effective.

ICD10 - ICD10 was delayed until October 1, 2015 and it’s clear that stakeholders are divided about the concept. One the hand, professional coders correctly identify that ICD9-CM is incomplete and does not include several important disease states. On the other hand ICD10-PCS is so complex that it is unlikely clinicians will not be able to produce the documentation needed to justify a code. The cost to the country post implementation in lost productivity will be enormous. If I could ask for a “do over” I would suggest that clinicians use SNOMED-CT to record clinical observations and that in a world of global capitated risk, not fee for service, the notion of using ICD for billing is no longer relevant. ICD was intended as an epidemiological classification, not a billing vocabulary. Only the United States uses ICD for billing and only the United States has proposed ICD10-PCS. 2015 will give us the next chapter in the debate.

In all industries, the concepts of social networking, mobile technology, analytics, and cloud hosting became increasingly important in 2014 for business and personal applications. Healthcare has been slow to adopt these techniques but increasing cost pressures and new business models are motivating healthcare IT departments to embrace cloud services. I believe that 2015 will be a tipping point, with increasing use of social networking concepts for care team communication, smart phones/tablets becoming the preferred tool for clinical work, real time decision support based on analysis of similar patients becoming mainstream, and cloud-based EHRs becoming essential for the agility of merging/changing organizations.

2014 was a year of increasing stress for CIOs, accelerating workflow change, regulatory burden, unquenchable demand for automation, and rapid technology evolution. 2015 may see less new regulatory requirements, more mature products in the marketplace, and an increased role for the private sector to innovate. As always, I remain optimistic for the future and am ready for the challenges ahead.

Thursday, December 25, 2014

It’s Christmas Day on Unity Farm and the every creature has had extra attention, special meals, and new toys.

What better gift for our livestock guardian dogs (Great Pyrenees) than soft fluffy beds in the barn loft? As the pictures below illustrate, this was an ideal gift - the most fun they have had all year tearing each bed into a 1000 pieces. It seems strange, but we made them deliriously happy with their gifts.

The ducks, chickens, and guinea fowl got fresh spinach greens from the hoop house, peas, mealworms, and oats. Below you’ll see them grazing in poultry heaven.

The alpaca got alfalfa with molasses, grain, and freshly cleaned stalls. Here’s a photo of Sunny, our baby alpaca, sitting in the Christmas Day sun with her grandma Ella.

The humans roasted root vegetables and Tofu. Gifts including warm clothes for the cold barn chores of January, books (paper and electronic) to read by the fire during the 100 days of winter, and a few updates to the home electronics we use every day.

One strange observation today - in a Monty Python-like event, a “killer squirrel” caught a goldfinch and began eating it, shown below. Comparisons to the “killer rabbit” of the Holy Grail abounded.

I spent the early afternoon with all the creatures given them extra play time and love.

Over the past 100 years, many cedar trees have lived and died on Unity Farm. Since cedar does not decay, the Unity forest is filled with fallen cedar. I spent the late afternoon hauling cedar trees to serve a trail edging along the Woodland trail. The trail is a bit obscured with leaves/snow in the winter and the cedar trunks will now guide the way year round.

All of the family - Kathy and me, my daughter, her partner David, David’s parents, my mother, and one of Lara’s friends are gathered together for the holidays. Unity Farm is buzzing with activity and I stand ready as master of ceremonies, plumber, electrician, farmer, and friend to make sure the warmth of the holiday season is enjoyed by all - a sort of Unity Farm bed and breakfast experience.

As I’ll write about next week, 2014 has been a year of remarkable change with new life, death, joy, sorrow, and endless activities. The family, the creatures, and the natural world around us are all healthy and happy. Who could ask for anything more?

Wednesday, December 24, 2014

I’m often asked by hedge funds, investors, and private equity firms to evaluate start ups based on their management savvy, product maturity, and business models.

I’ve been on several calls with startups in 2014 in which the grammar was all “present future tense”

"We will have a product that does…"

My response to the investors is to clarify

1. they will have a product that might...
2. they have a product that does...

There is a great difference between

"We will invent a flying car that does improve commuting"

and

"We have prototyped a drivable plane that has demonstrated reduced commute times of 50%"

When I was in my late teens and early 20’s (I was at Stanford 1980-1984) the PC revolution enabled young entrepreneurs to invent technologies in their basements that made millions after years of hard work.

Earlier this week, the New York Times published an article reflecting on the generation of entrepreneurs that followed me at Stanford, graduating in 1994 as the web began its hyper growth. Some made billions after months of work.

Now, there is a sense that an entrepreneur can write an app over a weekend and retire. There are enough folks “winning the lottery” with this approach that many believe a career that lasts until age 30 is enough to fund a comfortable retirement. That belief has led to present future tense, with folks promising that they have solved a complex problem before widespread adoption and customer satisfaction have really occurred.

Using a metric of adoption and satisfaction is a great countermeasure to present future tense.

KLAS recently issued a report about interoperability, defining simple versus sophisticated data exchange objectively as simple=pushing summaries, sophisticated=pulling documents. To me, getting simple interoperability fully integrated into workflow with high provider satisfaction, maximizing the meaningful use stage 2 transaction volume, is a good metric for 2014. You’ll see that using that metric reveals AthenaHealth and Epic achieved the combination of technology, adoption and satisfaction per the KLAS analysis.

Another framework to counter present future tense is Dixie Baker’s excellent JAMIA paper, “Evaluating and classifying the readiness of technology specifications for national standardization”

Many of the present future tense entrepreneurs have products that require standards which do not exist or are not yet deployed.

My advice to all those pitching to investors - either clearly state what is and what will be, or if you are speaking in present future tense, enumerate the gaps in technology maturity, adoption, and user satisfaction, so that everyone understands the business potential for the product without overstating its true market readiness.

Thursday, December 18, 2014

On Sunday, December 21, 2014 astronomical winter begins in the Northern Hemisphere (and ends on March 19, 2015).

All the animals and vegetables will be stressed for the next 100 days. It’s a cold and dark time that brings a struggle to survive. Here's a photo of a chilly morning along the railroad tracks at Unity Farm, taken by Gary Beach, a Sherborn resident and author of "The U.S.Technology Skills Gap".

One of our ducks, Mulan (they are named by my daughter for Disney princesses) died of pneumonia yesterday. She aspirated water while mating (ducks are rough) and although we treated her successfully with antibiotics, she had a relapse and died in a few hours. She’s buried in our Japanese shrine area. She was the most colorful of our flock, an endangered Welsh Harlequin. Her sister, Belle, lives on to carry forward the genome. In the Spring we may add a rare Ancona duck pair to the flock.

Jack, our last surviving rabbit, is 13 years old and in his last days. He’s blind in both eyes and recently had a stroke, paralyzing his lower body. We keep him warm and hydrated, feeding him his favorite food, fresh broccoli. He’s not suffering but is beginning to fade.

The local predators are finding it harder to stay warm and well fed, so they are venturing into the barnyard areas. A large Cooper’s hawk tried to grab a guinea fowl yesterday but my wife was able to chase the hawk away. Again today the hawk tried to capture a bird, but with 68 guinea fowl alarming, every one of them was able to get away.

The voles, moles, and mice continue to dig into the hoop house and I’ve placed peanut butter/carrots in the humane traps that enable me to keep the vegetables from being eaten. This week the count is 2 voles, 1 mole and 2 field mice trapped and moved half a mile away. I’ve cleared a few of the raised beds - chard, spinach, and turnips - and replanted mache, purple choi, and red romaine lettuce, all vegetables that will germinate in the 50 degree temperatures of the winter hoop house.

The holidays are approaching and we’ll have a household of relatives from December 22-December 31. There will be a few extra hands to help with the farm chores - tending the crops, caring for animals, and helping decorate the farm for the holidays.

There may even be some downtime to plan the projects of 2015, including the woodland planting of new permaculture food sources. Of the 15 acres of Unity Farm, 5 are pasture/meadow and 10 are woodland. By adding nut trees, berries, roots, herbs and flowers in the forest, we enhance the sustainability of the land while benefiting all nature's creatures that live here. Over the past 2 years we’ve finished the infrastructure improvements to the farm and added all the tools we need to keep it maintained. Our new frontier over the next few years will be creating a wonderland in the forest that surrounds us.

As you’ll see from the charter, each of the participants has agreed that all specifications and artifacts developed during the course of the project will be made available to the entire community via an Open Content License.

The scope of the work includes three deliverables:

FHIR Data Query Profiles. A set of FHIR Resources and accompanying profiles that enables query/response of the discrete data elements contained in the Meaningful Use Common Data Set. The work will be completed for inclusion in the May 2015 HL7 FHIR Draft Standard for Trial Use revision 2 ballot.

FHIR Document Query Profile. A FHIR resource and profile that enables query/response of IHE X* metadata resources, and specifically, transition of care and patient summary CCDAs. The work will be completed for inclusion in the May 2015 HL7 FHIR Draft Standard for Trial Use revision 2 ballot.
￼￼￼
Security Implementation Guide. Based on the SMART OAuth 2.0 and OpenID Connect profiles, a final guide will be completed the week of Apr 1, 2015. The Security Implementation Guide will eventually be incorporated in the HL7 balloting process, but for this project will be developed in parallel to accompany the FHIR Data Query and Document Query Profiles and Implementation Guides.

The Argonaut project is time limited and focused on just those three specific deliverables in 2015. It is not a new organization nor is it competitive with any other effort.

It leverages the existing Data Access Framework efforts from ONC, is compatible with the IHE MHD profile for document exchange, and provides incremental first steps in support of the broader Healthcare Services Platform Consortium initiative. It is complementary to the CommonWell and the various state/regional HIE initiatives.

Participation in Argonaut includes sponsors, pilot participants, and the community (anyone who wants to stay in touch with the progress of the work).

We’re working on a one page summary which will illustrate the value of the work to patients, providers, and payers as well as innovators who will find it much easier to develop modular applications using FHIR than the current CCDA over Direct approach required in Meaningful Use Stage 2.

Finally, we’ve been very careful to decouple the Argonaut work from Meaningful Use. Although we believe FHIR should be included in future certification testing, it should not be a regulatory requirement until appropriate pilots, testing, and revision are completed. We’ll use the six objective maturity and adoptability criteria enumerated by the Standards Committee to evaluate the appropriateness of FHIR for the Meaningful Use program including:

I believe the combination of FHIR/OAuth/REST will align well with the stated goals/objectives of the Federal Healthcare IT Strategic plan and the upcoming Interoperability Roadmap.

FHIR will not solve every problem and we need to be careful to under promise, but the notion of a learning healthcare system based on the kind of data liquidity we have in other aspects of our lives (social media, electronic banking, smartphone apps) seems like the right trajectory to me.

Thursday, December 11, 2014

The reality of farming is that it creates dependency on the farmer - animals, plants, and infrastructure need to be supported 365 days a year. This week, I had a failure of my personal anti-virus software (and my flu shot) and developed the 2014 flu. My wife, who has been my life partner for 35 years, took over my tasks feeding, watering and cleaning all our animal areas while my energy was reduced. At nearly 53 years old, my endurance is boundless, but the flu does reduce my physical abilities. Illness has caused us to realize that we have to be careful to balance to the joys of farming with our capacity to maintain what we’ve built. Farming during winter with its cold, ice, snow, sleet, and wind takes a toll on even the most fit.

I did work from home two days this week as a courtesy to those around me - I did not want to infect anyone.

As we head into the coldest part of winter, the tasks turn toward indoors. Kathy and I emptied the pantry and root cellar then reorganized everything keeping only those foods that were still fresh and appealing. We’ll do the same with our vegetable and mushroom supplies in the farm refrigerator this weekend.

I cleaned out the barn loft and did some electrical work in the barn in preparation for wiring the cider house to the power grid.

My father-in-law’s death a month ago provided us with several indoor projects as we go through his belongings and sort them into the donate, keep, and resell piles. We’re busy working on trust accounts/wills, transfer of assets across two generations, and canceling credit cards/accounts.

There is alpaca fiber to sort, holiday decorations to put up, and attic/basement cleaning to do.

I continued vole patrol (and humane trapping) in the hoop house, ensuring that our winter vegetables are not being eaten.

There’s paperwork, taxes, and licenses to complete. Last May I applied for Unity Farm to become a bonded winery so that we can sell our hard cider. The application is multi-step and quite complex. At this point all our applications are complete and we’re awaiting the scheduling of a site visit to inspect our cider house and fermentation/bottling facilities.

The alpaca, dogs, chickens, guinea fowl, ducks, and bees have all adapted to their winter life. The mammals are clustered together in the barn at night keeping warm and dry. The chickens and guinea fowl roost early in their heated coops. The ducks seem to enjoy the wet, frozen mud and have no issue with inclement weather.

The humans (include those of us recovering from the flu) are sitting next to a cozy fire, under a blanket, and using the winter months as a kind of hibernation, recharging our batteries for the rigors of the spring to come.

Wednesday, December 10, 2014

The December HIT Standards Committee included a review of the draft Federal Health IT Strategic Plan , recommendations about identity management from the Transport and Security Workgroup, an overview of the Prescription Drug Monitoring Program, and a discussion of upcoming task force work as we all prepare for the publication of the ONC interoperability roadmap and the Meaningful Use Stage 3 Notice of Proposed Rulemaking.

The meeting began with an introduction from Jon White, the new Acting Deputy National Coordinator. We all know Jon from his leadership of IT initiatives at AHRQ. He brings new energy and insight to ONC. A great choice.

I summarized the agenda for the day but also told the group about the Argonaut Project, to clear up any misunderstanding. The leadership of HL7 wanted to be responsive to work of the JASON task force and ensure HL7 had the necessary standards/implementation guides to support the emerging demand for query/response interoperability. HL7 needed some additional funding to produce the deliverables by mid-2015. A cross section of stakeholders passed the hat to provide HL7 extra funding. Since we’re helping to accelerate JASON deliverables, we thought that those supporting HL7’s work could call themselves the Argonauts.

1. One which enables query/response of the discrete data elements in the Meaningful Use Stage 2 Common Data Set from an endpoint
2. One which enables query/response of unstructured data from an endpoint

using RESTful transport, and OAuth2 enforced authentication between the querier and the responder.

These initial deliverables are a subset of DAF and a subset of HSPC goals, scoped for May 2015 delivery.

Seth Pazinski and Gretchen Wyatt presented the draft Federal Health IT Strategic Plan which has 5 goals, 14 objectives and summarizes the input of 35 federal agencies. It is well aligned with the triple aim and includes increased collection, sharing, and use of healthcare data. The next step is for ONC to name two Standards Committee liaisons to the Health IT Policy Committee Strategy and Innovation workgroup, which is charged with providing comments on the plan.

1. To strengthen the authentication currently certified in EHR technology
a. Continuously protect the integrity and confidentiality of information used to
authenticate users, using the standard specified in §170.210(a)(1) of the 2014
Edition EHR Standards, Implementation Specifications, and Certification Criteria.
b. If passwords are used for user authentication, accept only passwords that meet
the guessing entropy guidelines set forth in Appendix A of NIST 800-63-2.

2. To enable EHR technology to be certified for having implemented multi-factor
authentication, recommend the following certification criterion:
a. Restrict access to the system, or to one or more individual functions within the
system (e.g., prescribing controlled substances), to only those individuals who have presented at least two of the following three forms of authentication -- knowledge of a secret (e.g., password), possession of a physical object (e.g., hard token or smartcard), a biometric (e.g., fingerprint).

We had a rich discussion about the intersection of security technology and policy. Ultimately, we decided to be less prescriptive and removed 1b. password entropy as a requirement. Instead, ONC, the Transport and Security Workgroup, and NIST will work together on an update to 800-63-2 which will include a risk-based framework. Each healthcare organization will mitigate password risk using technologies and policies which adhere to the framework.

The committee offered several recommendations to align the PDMP program with emerging standards activities such as FHIR. Although the backend connections between PDMP sites and between pharmacies might use NCPDP or NIEM approaches, the EHR connections are better accomplished with FHIR approaches.

Finally Steve Posnack described two tasks forces, one for evaluation of the S&I Framework and another for a review of the S&I Provenance work done to date. The HIT Standards Steering committee will work with Steve to assign workgroup members to these task forces. He also described the Certification Program Open Test Method Pilot. We asked that any certification script writing be done using agile methods with pilot testing and engagement of the stakeholder community to achieve the minimum necessary burden in certification processes.

A great meeting with positive energy from all the Standards Committee members to support ONC at a time of great change.

Friday, December 5, 2014

As the snow falls and windy/moist winter weather envelops the farm, the work has become a combination of managing warmth, tending the vegetables in the hoop house, and indoor activities.

Woodlot management has become my major winter exercise - walking the trails and inspecting the forest for fallen trees, broken branches, and pieces of long dead cedar that have not decayed. I’m still working on processing ash trees that fell during Hurricane Sandy. Ash does not need to be aged and becomes instant firewood. I do my best to leave stable dead trees in place so they can become bird habitat .

I leave fallen/decaying logs in place as they are an important source of food and shelter to many species. Up to 20% of the species living in the Unity Farm forest depend upon dead trees and fallen debris.

However, I do harvest freshly fallen trees/branches, cedar, and leaning trees that are caught by other trees. The technique for cutting leaning trees is challenging and dangerous so I hire professionals to take down the larger trees that are likely to cause me harm.

I've divided the property in zones per the lessons I learned from The Resilient Farm and Homestead: An Innovative Permaculture and Whole Systems Design Approach by Ben Falk, which I read on my Kindle Paperwhite while traveling. This weekend, I'll be in Zone 3, which includes areas accessible by our trails that I visit at least once per week. In the upcoming weeks, I'll work in Zones 4 and 5, those in the deeper parts of the forest that accessible only by wandering off our trails. Since the snow has melted the fallen cedar is again visible and I'll be cutting/stacking over 50 years of fallen cedar on the western border of the property.

The cold has had an unexpected effect on the hoop house. Large numbers of voles have burrowed under the hoop house walls (and the 3 inch deep hardware cloth that surrounds the building). A entire family set up a vole household in the bed of Japanese purple carrots. Voles can eat a lot of carrots. I placed humane traps in the raised beds, using carrots as bait. Thus far I've removed 8 voles including this chubby fellow

This Spring we'll be repaving the 25 year old farm driveway and running electrical conduit from the barn to the cider house. In anticipation, I'll begin wiring the cider house with a barn light (we generally clean up from a day of apple crushing in the dark), and provide power for our future expanded honey and cider production which are likely to overtake our ability to hand crank the extraction methods - 600 pounds of honey and 6000 pounds of apples. Another typical farm weekend of woodlot management, vole removal, and electrical wiring!

In a vendor neutral approach, Cerner, Epic, Meditech, Athena, McKesson, The Advisory Board and several provider organizations agreed to provide acceleration funding and political will to ensure that HL7 implementation guides which enhance query/response interoperability are available by May 2015.

Two FHIR profiles implemented via a public, RESTful Application Program Interface, protected by OAuth2 are needed. The first is the discrete data elements specified by the Meaningful Use Common Data Set. The second is document retrieval.

(1) Patient name.
(2) Sex.
(3) Date of birth.
(4) Race – the standard specified in § 170.207(f).
(5) Ethnicity – the standard specified in § 170.207(f).
(6) Preferred language – the standard specified in § 170.207(g).
(7) Smoking status – the standard specified in § 170.207(h).
(8) Problems – at a minimum, the version of the standard specified in § 170.207(a)(3)
(9) Medications– at a minimum, the version of the standard specified in § 170.207(d)(2).
(10) Medication allergies – at a minimum, the version of the standard specified in § 170.207(d)(2).
(11) Laboratory test(s) – at a minimum, the version of the standard specified in § 170.207(c)(2).
(12) Laboratory value(s)/result(s).
(13) Vital signs – height, weight, blood pressure, BMI.
(14) Care plan field(s), including goals and instructions.
(15) Procedures –
(i) At a minimum, the version of the standard specified in § 170.207(a)(3) or §
170.207(b)(2).
(ii) Optional. The standard specified at § 170.207(b)(3).
(iii) Optional. The standard specified at § 170.207(b)(4).
(16) Care team member(s).

Imagine the ecosystem of apps that could be created if simple read/write interoperability of these data elements was available in all mainstream EHR/PHRs with security controlled by the user of the EHR/PHR.

ONC also posted a blog describing on the importance of data liquidity among all patients, providers, and payers.

As I’ve written previously, it’s a perfect storm for innovation when stakeholders, resources, and political will align.

The Argonaut Project is a great example of policy and technology solving real problems in a reasonable timeframe driven by the value proposition that interoperability via open standards benefits all.